Senior Medical Director, Clinical Sciences, Oncology

The Senior Medical Director will function as clinical leader of a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase), under leadership of Program Lead Medical Director (Program Lead MD). The incumbent will also lead multi-disciplinary teams charged with guiding clinical development and subsequent regulatory submissions and may directly lead Medical Directors.

As a Senior Medical Director, a typical day may include the following:

• Provides clinical leadership and responsible for all clinical deliverables with minimal supervision from Program Lead MD. Clinical deliverables may include individual protocols consistent with the Clinical Development Plans (CDP); clinical components of regulatory documents/registration dossier and brand related medical information, clinical communication and publications

• Manages all operational aspects and drives execution of the section of the clinical program in partnership with global line functions, assigned Clinical Scientist and Clinical Operations associates

• Ensures timely execution of assigned clinical deliverables within approved budget

• Supports Program Lead MD and frequently lead interactions with external (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups) and internal stakeholders (e.g., Research, Early Clinical Development, Medical Affairs, Marketing, HE&OR), and internal decision boards

• Contributes to CRF’s, outsourcing specifications, data monitoring and validation plans, analysis plan for all trials to ensure consistency within the program

• Contributes/Leads development of clinical sections of program level regulatory documents such as Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions with minimal input from Program Lead MD

• Ensures career development of GCD colleagues through active participation in the performance management and talent planning processes. Provides on-boarding, training, and mentoring support and contributes to the performance evaluation of GCST members as appropriate

• Serves frequently as member for GCD training programs, author or reviewer for clinical SOPs. May contribute to GCD strategy by serving on task-forces or other panels

This role may be for you if:

• Strong management, interpersonal, communication, negotiation and problem solving skills

• Considerable organization awareness (e.g., inter-relationship of departments, business priorities), including significant experience working cross-functionally

To be considered for this role, you must have an MD or MD/PhD and>4 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. Additionally, >3 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing), or section of clinical programs in a global/matrix environment in pharmaceutical industry. We are seeking people management experience, this may include management in a matrix environment. Understanding of global regulatory environment including key regulatory agencies and approval processes. We are seeking a strong understanding of operational aspects of all phases of clinical trial conduct (start-up, conduct, close-out).